Blood Biomarker of Alzheimer's Disease (AD)

NCT03340571 | Completed

• 1 other identifier: Pro00085997
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for stratification of Alzheimer's disease patients and healthy volunteers. This study may lead to future blood tests that may help earlier diagnosis of Alzheimer's disease and detect the disease progression.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; biomarkers; blood

Outcome Measures

Primary Outcomes (1)

• Biological marker of Alzheimer's disease

  Test for blood biological marker of Alzheimer's disease, mtDNA damage

  Day 1

Study Arms (2)

Alzheimer's Patients

Healthy Volunteers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research coordinator(s) will review the clinic schedule in the Memory Disorders clinic at Duke University for potential patients who meet the basic inclusion/exclusion criteria who have appointments that day. While consenting AD potential subjects, the study team may also ask their caregivers who accompany the AD patient to the clinic if they would also like to be part of the study and possibly enroll as a Healthy Control subject.

You may qualify if:

• Alzheimer's Disease Patients:
• years and older
• AD patient who is seen at the Memory Disorders Clinic
• AD diagnosis
• Non smoking
• No cancer treatment in the last 5 years
• Informed consent from the patient or the patient's legally authorized representative (LAR)
• Patient and/or LAR able to read and speak English
• Healthy Control Participants:
• years and older
• Non smoking
• No cancer treatment in the last 5 years
• Age matched to AD subject
• Able to read and speak English

You may not qualify if:

• Alzheimer's Disease Patients:
• Known additional neurological disease
• Healthy Control Participants:
• Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Laurie Sanders, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 13, 2017
• Study Start: March 12, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)